The invention relates to an absolutely novel use of cow urine distillate as activity enhancer and availability facilitator for bioactive molecules including anti-infective and anti-cancer agents. The molecules which express any activity in form of either inhibiting or promoting a biological function have been referred in this invention as bioactive molecule e.g. antibiotics, drugs, nutraceuticals, cardiovascular, hepatoprotective, neuro-tonics etc. The present invention has direct implication in drastically reducing the dosage of antibiotics, drugs and anti-cancer agent while increasing the efficiency of absorption of bioactive molecules.
In Ayurveda cows urine is suggested for improving general health. But it is never scientifically tested for any utility alone. The applicants have developed the curiosity about this component in the preparations and asked many questions to them; whether the component cow urine is having any activity by itself or it does not have any activity but enhance the activity of other components in the preparations? What are the components present in the urine of cow? Whether the urine contains microorganism, which are beneficial? Whether the degradation products from the urine are beneficial? To answer these questions the applicant obtained xe2x80x9cKamadhenu Arkaxe2x80x9d the urine distillate from xe2x80x9cGo-Vigyana Anusandhana Kendraxe2x80x9d Nagpur, India. This is the urine distillate suggested for drinking to improve the general health and sold and distributed in different size bottles. The applicants tested the urine on Luria agar and broth in sterile condition and did not notice any growth of microorganism. To test whether this is inhibitory to growth of different microorganism, Escherichia coli and Mycobacterium smegmatis were grown at different temperatures ranging from 20 to 40xc2x0 C. in presence and in absence of the cow urine distillate, no significant difference in the colony count is noticed. Surprisingly, the same distillate enhanced the antibiotic action on these bacteria leading to this invention. The novelty of the invention lies in the fact revealed through precise experimentation that the enhancement action and its effectiveness is achievable only in the range of concentration which is literally in nano to micro molar levels. And when a higher concentration/dosage is used in the formulation or combinations the activity(ies) do not appear. That should be the reason for non-detection such a valuable potential of cow urine (Go-mutra). From million doses of annual antibiotics consumption goes waste as these could not be utilized or targeted to the infective organisms effectively due to various factors like efficient absorption, transportation to the target site, retention time, operation of efflux pump, metabolism etc. Thus, large portions of the drugs we apply are wasted and only a miniscule percentage is being targeted to the infective microbes. Also, the unutilized drug/antibiotic amount remains as a load in the body and environment acting as a selection pressure to facilitate emergence of drug resistance in parasites and their predominance, ultimately leading to failure of antibiotics against resistant infections. This also is responsible for side effects, illness and reduction in life expectancy being more acute in the older population. One of the ways, which has been feasible to reduce drug dosage, has been synergism between two therapeutic agents. However, if both have the antibiotic property, still the problem of continued selection pressure on microbes is likely to continue. So, the applicants thought of utilizing cow urine, which is not microbicidal but when present with a drug or active molecule, enhance its activity and availability (bioenhancers). This way, the selection pressure will be counter-balanced simultaneously reducing the dosage of antibiotics or drugs for minimizing the side effects, which has also high commercial importance.
The present invention was the result of planned experiments to provide a novel method for improving activity and bioavailability of antibiotics, drugs and other molecules using xe2x80x98cow urine distillatexe2x80x99 in different formulations.
The bioavailability of nutrients and enhancement antibiotics effect is relevant to human, plant as well as animal health and thus the compositions and methods of the invention are also intended to be used in agriculture and veterinary practice.
Cow""s urine (Go-mutra) can be considered as the most effective animal origin substance/secretion with the capacity of general health improvement but it does need substantiation through scientific experimentation. Thus, the applicants considered it worthwhile to scientifically look at this and define the molecular basis of the values through in vitro and in vivo assays. The applicants in the first instance probed whether it contained any drug facilitator elements since such a property would make it a highly useful natural substance. In recent days, use of xe2x80x98piperinexe2x80x99 as a bioavailability enhancer has been described (U.S. Pat. Nos. 5,616,593 and 5,972,382). Till today thus, the known bioavailability enhancer documented is piperine and a series of inventions related to this compound have been described in the following prior arts.
The main objective is to provide new use of the bio-active fraction as a bio-enhancer and as a bioavailability facilitator.
In another objective of the invention is to provide method for improving activity and bioavailability of antibiotics, drugs and other molecules using active fraction from cow urine distillate.
Still another objective of the invention is to provide a process for the extraction of the active fraction form the cow urine.
The invention relates to new use of a known abundantly available cow urine distillate as an enhancer of antibiotic action on the target. The molecule of invention helps in the absorption of antibiotics across the cell membrane in animal cells, gram positive and gram negative bacteria. Similar activities can also be obtained by using the distillate of the urine of cow at 40-50xc2x0 C. and from the concentrate, which is lyophilized and dissolved for further use. Further the urine distillate from buffalo, camel, deer provides similar activity of bioavailability.